Serious Event

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Serious Event

Serious Adverse Events (SAEs) are adverse events that result in death, are life-threatening, require or prolong hospitalization, cause persistent or significant disability/incapacity, or are congenital anomalies/birth defects. Each serious event is categorized by term, organ system, assessment type, and source vocabulary to provide standardized reporting across clinical trials.

Serious Event path is as follows:

Study -> Results Section -> Adverse Events Module -> Serious Event

Study -> Results Section -> Adverse Events Module -> Serious Event -> Serious Event Stats

Serious Event

Ignite Creation Date: 2025-12-24 @ 9:56 PM
Ignite Modification Date: 2025-12-25 @ 7:34 PM
NCT ID: NCT03978832
Term: increase in liver enzymes
Organ System: Hepatobiliary disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA 22.0
Notes: 49 days after the last dose of PERSERIS, the participant developed increased liver enzymes reported as clinically important. The event resolved by Day 157 without intervention and was considered unrelated to study treatment by the investigator.
Study: NCT03978832
Study Brief: Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 23 View